'Objectionable Conditions' Persist at Drug Compounding Facilities
"This is additional evidence, in our view, that Congress needs to close the regulatory gaps and update FDA authority to reflect what is an evolving pharmaceutical marketplace where need for specific dosage forms or unique variations of sterile compounded products that go above and beyond traditional pharmacy compounding done pursuant to a patient prescription."
The GAO report drew numerous other conclusions, most of which have been reported since September's national compounding drug disaster. That's when an injectable steroid drug compounded by the New England Compounding Center in Framingham, MA, was found to be contaminated with a fungal toxin that has so far killed 63 people and sickened nearly 700 others in 20 states.
These issues are of grave concern to hospitals. According to a U.S. Office of Inspector General report issued in April, 92% of hospitals use compounded products, 92% of these use sterile-to-sterile products and 25% use non-sterile to sterile products.
"Of the hospitals that used nonsterile-to-sterile compounded sterile preparations, 85% outsourced at least some of these products [i.e., purchased them from outside pharmacies].
- 'Kafkaesque' Value System Unfairly Penalizes Doctor Pay
- Proton Beam Therapy Poised for Growth in US
- mHealth Tackles Readmissions
- CNO Leads $1M Charge for New Scrubs, Uniforms
- Some Cancer Hospitals' Quality Data Will Soon Be Public
- 4 Crucial Tactics for Reining in Healthcare Cost
- How Digital Strategy Shapes Patient Engagement at Boston Children's Hospital
- How, and Why, to Recruit Male Nurses
- Half of All Primary Care, Internal Medicine Jobs Unfilled in 2013
- Docs Fret as HHS Addresses Malpractice Reporting 'Loopholes'